Kornimate/medical-research-clean huggingface dataset:
nicotinamide in the treatment of psoriasis

Conditions: Psoriasis

Summary: this study will determine if combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis.

current treatment strategies of psoriasis are not completely satisfactorily. by inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. preliminary studies have shown that nicotinamide, which is a vitamin b derivative, is effective in the treatment of psoriasis. according to lack of data, we will investigate the beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate psoriasis.

Eligibility criteria:
inclusion criteria: * men and women of 18 to 65 years old, * mild to moderate psoriasis; patients must have had less than 15% of the involved body surface, symmetrical plaques (bilateral lesions) or two plaques at least 5 cm apart on the same side of the body with plaque size greater than 2 × 2 cm, but smaller than 15 × 15 cm. * willingness to participate exclusion criteria: * those who used any medication or niacin and multi-vitamins two weeks, or anti-psoriatic systemic drugs or beta-blockers one month prior to the study, * pregnant women, * those with the history of renal, hematologic, liver and major psychiatric diseases, * those with only scalp, nail, flexural, palmoplantar, or pustular psoriasis.
prospective studies of the use of self hypnosis, acupuncture and osteopathic manipulation on muscle tension in children with spastic cerebral palsy

Conditions: Spastic Cerebral Palsy

Summary: we propose to identify patients and families for inclusion in pilot studies of the three modalities. patients and their families will be asked to participate in these studies. our research group has done some preliminary work with the modality of hypnotherapy, but has no experience to date with the other two modalities. the idea to try relaxation techniques was generated by the observation that there is great variation in the degree to spasticity at different times in the same patient with cp. when queried, mothers responded that they were able to get their child to relax and decrease the tension in their muscles by stroking, talking softly, and/or by playing certain types of music. the availability of hypnosis and training in self-hypnosis was presented to several families of our patients. their understanding and acceptance of this alternate therapy was gratifying. the results of this therapy have been promising and have encouraged us to proceed with this modality and to consider making other nonconventional modalities available to our patients. we hypothesize that at least one of the two modalities will be accepted readily by patients with cp and their families, and with their acceptance compliance with the method chosen will be at levels of 80 percent or more.

the primary objective of this project is to develop and evaluate two different alternative or complementary medical modalities that have been used in children with cerebral palsy by practitioners in an attempt to decelerate the complications from the neurologic insult and resultant muscle imbalance. the specific aims are: 1) the development and incorporation of two alternative modalities (osteopathic manipulation and acupuncture) into available services in southern arizona for individuals with cerebral palsy. 2) the evaluation of the uptake of and compliance with the two modalities in the clinical services for cerebral palsy. 3) conduct pilot studies of each of the two modalities to determine their efficacy in decreasing the degree of muscle tension in children with spastic cerebral palsy.

Eligibility criteria:
inclusion criteria: * children with a diagnosis of spastic cp who are between 48 months and 21 years of age. * for the hypnotherapy-control arm the children must have a cognitive level sufficient to allow them to visualize and enter into trance. * the cognitive level criteria will not apply to the manipulation-acupuncture-control arm of the study. * no child will be excluded on the basis of gender, race or culture.
rheopheresis mechanism in hemodialysis patients with pad

Conditions: Hemodialysis

Summary: peripheral arterial disease (pad) is common in chronic hemodialysis patients (hdc) with a prevalence of 30% according to the dopps study. the combination of pad and chronic kidney disease (ckd) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years. ischemia occurring during pad is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability. it is responsible for painful skin wounds whose healing is poor, with a significant risk of infection. in patients with chronic renal failure, it is linked to both: * local phenomena (atherosclerosis, calcification) * changes in blood viscosity (elevated hematocrit and inflammatory proteins, especially fibrinogen) * a neovascularization defect (uremic toxins, in particular indoxyl sulphate). if revascularization is not possible, amputation remains the only possible treatment to relieve pain and limit the risk of infection. rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins. this would reduce blood viscosity and red blood cell (rbc) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation. several studies have investigated the efficacy of rheopheresis in pad in hdc, but the level of evidence remains low.

the main objective of our study is to evaluate the impact of rheopheresis on blood (main objective) and plasma viscosity, skin microcirculation and blood coagulation (fibrinography, thrombin generation). no study has evaluated the direct effect of rheopheresis on these different parameters. however, a better understanding of these mechanisms would make it possible both to optimize the effectiveness of the technique, to limit its potential side effects and the cost of treatment.

Eligibility criteria:
inclusion criteria: * age 18 years or more and included in the rheopad protocol (2019-a01513-54) * esrd treated by hemodialysis or hemodiafiltration * pad-lti with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion, subject to the feasibility of the measures: arterial pressure assessment at the ankle \<70 mmhg, or toe pressure 30 mm hg, or transcutaneous oximetry measurements \< 40 mm hg * interventional or surgical revascularization either not technically possible or no necessary * medical insurance * signed informed consent exclusion criteria: * - uncontrolled infection despite well-conducted antibiotic therapy * life expectancy \< 1 year * severe cognitive or psychiatric disorders * pregnant woman, parturient, nursing mother * patients unable to give an informed consent or unwilling to participate in the study
triclosan-antibacterial sutures efficacy on the incidence of surgical site infection in clean-contaminated wounds

Conditions: Surgical Site Infection; Surgical Wound; Surgical Wound Infection

Summary: comparing the incidence of ssi in cases using coated polyglactin 910 suture with triclosan and cases using polyglactin 910 suture without triclosan in clean-contaminated wound surgery

comparing the incidence of surgical site infection (ssi) in cases using coated polyglactin 910 suture with triclosan and cases using polyglactin 910 suture without triclosan in clean-contaminated wound surgery. also, comparing the post hospital stay.

Eligibility criteria:
inclusion criteria: * age: 18-75 * clean-contaminated wound surgery exclusion criteria: * patient has immunodeficiency disorder. * patient receiving anti-cancer / immunosuppressive therapy. * patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
study the efficacy and safety of ptk 0796 in patients with complicated skin and skin structure infection (csssi)

Conditions: Infectious Skin Disease; Bacterial Skin Disease

Summary: a phase ii trial to demonstrate the safety and efficacy of ptk 0796 in the treatment of complicated skin and skin structure infections (csssi).

the pharmacologic profile of ptk 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. data from in vitro and animal studies support this hypothesis. in ptk 0796-cssi-0702 the safety and efficacy of ptk 0796 in the treatment of csssi will be compared to an antibiotic approved for this indication by fda. initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility criteria:
inclusion criteria: 1. patients, ages 18 years to 80 years 2. has an acute complicated skin and skin structure infection 3. female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug exclusion criteria: 1. has received an investigational drug within past 1 month 2. has been previously enrolled in this protocol 3. has received \>48 hr of a potentially effective systemic antibiotic immediately prior to study drug 4. is nursing

Keywords: csssi
comparison of blood loss following total hip arthroplasty with the use of three thromboprophylactic regimes: dabigatran, enoxaparin and rivaroxaban.

Conditions: Hip Osteoarthritis; Blood Loss

Summary: the purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (thr).


Eligibility criteria:
inclusion criteria: * primary, end-stage hip osteoarthritis requiring total hip arthroplasty exclusion criteria: * inflammatory arthropathies * liver disorders * neoplastic conditions * clotting disorders
closure of anastomotic leaks in the stomach and esophagus by endoscopic suturing

Conditions: Postoperative; Anastomosis, Surgical

Summary: patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.


Eligibility criteria:
inclusion criteria: * leakage at anastomosis within 2 weeks after upper gastrointestinal (gi) resection exclusion criteria: * tubular ischemia of the upper gi tract * inability to provide informed consent

Keywords: surgical leak endoscopic suturing anastomotic leakage esophageal or gastric resection
study of aro-ang3 in healthy volunteers and in dyslipidemic patients

Conditions: Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of aro-ang3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * on a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study * normal electrocardiogram (ecg) at screening exclusion criteria: * clinically significant health concerns * regular use of alcohol within one month prior to screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * recent use of illicit drugs * use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to normal healthy volunteers) note: additional inclusion/exclusion criteria may apply, per protocol
respiratory training in hemodialysis patients

Conditions: Chronic Kidney Diseases

Summary: patients with chronic kidney disease in hemodialysis have complex syndrome with diverse effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and endocrine-metabolic systems. with regard to the musculoskeletal structure, there is progressive muscular loss with consequent increase in muscle weakness, limited resistance, exercise intolerance and fatigue, as well as functional and morphological abnormalities characteristic of uremic myopathy. respiratory muscles are also affected as a result of uremic myopathy, with decreased strength and resistance. objective: to analyze the impact of respiratory muscle training on muscle strength, functional capacity and quality of life of patients with chronic kidney disease on hemodialysis. method: this is a prospective, randomized study involving 46 patients followed by the dialysis unit of a university hospital, over 18 years old, of both genders who underwent hemodialysis for more than six months and who signed the informed consent form. patients will be allocated into two groups: respiratory muscle training with powerbreath and control. all will be evaluated for demographic data, respiratory muscle strength, lung function, functional capacity and quality of life. the intervention group will perform three months of intradialytic training of a physical therapy protocol with powerbreath. both groups will be reevaluated after three months.


Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease undergoing hemodialysis for more than 6 months both genders * ged 18 years or older * clinically stable * who agreed to participate in the study by signing a free informed consent form exclusion criteria: * patients with previous or current myoarticular or neurological disease; * that require some urgent or elective surgical intervention during the protocol; * any cardiac decompensation such as arrhythmias, systolic blood pressure greater than 200mmhg or less than 60mmhg, diastolic blood pressure greater than 120mmhg or less than 40mmhg; * decompensated diabetes mellitus and acute systemic infection

Keywords: respiratory muscle strength renal insufficiency respiratory muscle training
postmarketing surveillance study of berodual® metered-dose inhaler in chronic obstructive airways disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * patients of either sex, including children over 6 years * chronic obstructive respiratory tract disease. every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with berodual® metered dose inhaler (mdi) exclusion criteria: * contraindications listed in the instructions for use/summary of product characteristics of berodual® metered-dose inhaler
evaluating bactisure wound lavage in orthopedic wounds

Conditions: Infection of Total Knee Joint Prosthesis

Summary: to demonstrate a reduction of debris in knee synovial fluid as demonstrated by wbc cell counts before and after irrigation with bactisure wound lavage.

this study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. wbc cell counts will be compared before and after articular irrigation with bactisure wound lavage. this study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in i \& d or reoperation (revision) total knee arthroplasty procedures. a maximum of seven study centers will enroll a maximum of 40 subjects.

Eligibility criteria:
inclusion criteria: * patient is undergoing i \& d or reoperation (revision) surgery for an infected primary tka. * patient is 18 years of age or greater. * patient is skeletally mature. * occurs within 30 days of the operation or within 1 year or more if an implant is present * involves deep soft tissues (e.g., fascia and/or muscle) of the incision * patient is willing and able to provide written informed consent. * patient is willing and able to complete scheduled follow-up evaluations as described in the protocol exclusion criteria: patients will be excluded from this study if: * patient is unwilling or unable to give consent or to comply with the follow-up program. * known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution * multiple (\>1) infected implants * medically unfit for irrigation \& debridement procedure * pregnancy * the patient is: * prisoner * mentally incompetent or unable to understand what participation in the study entails * anticipated to be non-compliant.

Keywords: primary total knee infection
a phase 2 study of viagenpumatucel-l (hs-110) in patients with non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: determine whether viagenpumatucel-l combined with low-dose cyclophosphamide prolongs survival in patients with nsclc who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.

this study will test whether vaccination with viagenpumatucel-l combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (nsclc) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. patients will be randomized 2 to 1 into the viagenpumatucel-l arm and the chemotherapy alone arm, respectively.

Eligibility criteria:
inclusion criteria: * non-small cell lung adenocarcinoma * at least 2 and no more than 3 prior lines of therapy for incurable or metastatic nsclc * suitable for conventional single agent chemotherapy * disease progression at study entry * eastern cooperative oncology group (ecog) performance status (ps) ≤ 1; ps=2 patients may be considered * central nervous system (cns) metastases may be permitted but must be treated and neurologically stable * adequate laboratory parameters * willing and able to comply with the protocol and sign informed consent * female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation exclusion criteria: * received systemic anticancer therapy or radiation therapy within the previous 14 days * received more than 3 lines of prior conventional therapy for advanced disease * human immunodeficiency virus (hiv), hepatitis b or c, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy * any condition requiring concurrent systemic immunosuppressive therapy * known immunodeficiency disorders * known leptomeningeal disease * other active malignancies * prior treatment with a cancer vaccine for this indication * pregnant or breastfeeding

Keywords: lung cancer gp96 vaccine immunotherapy heat biologics cyclophosphamide vinorelbine erlotinib gemcitabine paclitaxel docetaxel pemetrexed
an effectiveness and safety study comparing oxybutynin chloride plus flomax (tamsulosin hcl) and placebo plus flomax (tamsulosin hcl) for the treatment of lower urinary tract symptoms.

Conditions: Urination Disorders

Summary: the purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin hcl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total international prostate symptom score (i-pss) from baseline to week 12 or the final visit.

the objective of this double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg per day for 12 weeks in conjunction with an alpha-blocker for the treatment of lower urinary tract symptoms (luts). the hypothesis of the study is that oxybutynin extended release tablets 10 mg plus tamsulosin 0.4 mg will be more effective than tamsulosin 0.4 mg plus placebo in the treatment of lower urinary tract symptoms as measured by change of the total international prostate symptom score (i-pss) from baseline to week 12 or the final visit. safety assessments include peak flow rate (pfr) and post-void residual (pvr) volume, adverse events, vital signs and physical exams. patients will receive oxybutynin extended release 10 mg plus tamsulosin 0.4 mg or placebo plus tamsulosin 0.4 mg every day for 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of lower urinary tract symptoms with urgency and frequency with or without urge incontinence * have had at least 4 weeks of 0.4 mg/day tamsulosin therapy * an international prostate symptom score (i-pss) \>=13 * irritative component i-pss score \>= 8 * max flow \>= 8ml/sec with voided volume \>= 125 ml, post-void residual volume \<= 150 ml on two occasions. exclusion criteria: * clinically significant medical problems or other organ abnormality or pathology * prostate-specific antigen (psa) \>= 4 ng/ml * history of inability to empty bladder completely or not at all * uncontrolled narrow angle glaucoma * history of any prostate surgery or treatment * history of significant gastrointestinal problems.

Keywords: lower urinary tract symptoms ditropan xl oxybutynin extended release tablets